Tag: FDA
U.S. FDA Lifts Partial Clinical Hold for Mersana’s XMT-1522
The United States Food and Drug Administration (FDA) has lifted the partial clinical hold on the Phase I study of XMT-1522, a Dolaflexin® Antibody-drug...
Environmental Risk Assessment and New Drug Development
1.0 Abstract
In our globalized world, human pharmaceutical residues and traces of other (chemical) down-the-drain contaminants have become an environmental concern. Following the detection of...
Novasep finalizes €11M bioconjugation facility in Le Mans, France
Thius week, following the World ADC Summit in Berlin, Germany, Novasep, a leading supplier of services and technologies for the life sciences industry, announced...
Drugs and Drug Hunters
All products of the creative process are a reflection of the individual makeup of the inventors. A painting by Mark Rothko looks like a...
Evolving CMC Analytical Techniques for Biopharmaceuticals
1.0 Abstract
During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a...
Modernization of Regulatory Protocol and Initiatives for Advancing Precision Medicine
Over the last decade, Targeted Therapies, Personalized and Precision Medicine have become part of our vocabulary, representing a new way of thinking in how...
Can the President Still Cure Cancer?
Forty- five years ago, in a room filled with congressional members from both sides of the isle, distinguished guests, and a contingent of press,...
Is The End of DTC Advertising of Prescription Drugs Near?
Marketing of prescription medications and medical devices directly to consumers has, for many years, been the focus of considerable - ongoing - debate.
Proponents argue...
Looking Ahead to 2020: Global Antibody-drug Market Prediction
Cytotoxic drugs used in the treatment of solid tumors and hematological malignancies have, over the last 50 years, changed the natural progression of these...
Goodwin Biotechnology partners with Aspyrian Therapeutics in Near-Infrared Photoimmunotherapy (PIT) Process...
Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization or CDMO specialized in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell...
